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- 2026-04-15 18:24:24
- Company
- KRW 15M incentive to employees assigned to Organon
- by Jan 25, 2021 06:21am
- MSD Korea has promised to pay out an incentive of 15 million won and maintain the employee benefits for those who were notified to be transferred to a new subsidiary, Organon Korea. A pharmaceutical industry source reported today that MSD Korea has signed an agreement with the labor union on Jan. 22 after a long negotiation. First, MSD Korea has decided to provide an incentive of 15 million won to employees reassigned to Organon as a token of acknowledgement of their contribution to the company so far and encouragement for their new beginning. Moreover, Organon Korea would adopt the same employment relationship and condition as MSD Korea’s and ensure the job security for the labor union members transitioning to the new subsidiary. And when the employment condition is to change, they have agreed to actively engagement in communication. Especially, if the condition were to be revised in more disadvantageous ways for the employees, the management would require a consensus from the labor union with a majority of employees. In case of Organon Korea offering an early retirement proposal (ERP), the management has clarified to not forcefully demand the employee to take the offer against the expression of intention by the union. And for employees signing a salary agreement for two years (2021-2022) before coming June, the raise would be applied not only for in MSD Korea, but also for in Organon Korea. The Organon Korea management would also have to notify the labor union 60 days prior and sincerely negotiation for settlement, if it intends to split or merge the company, or sell off a part of or the whole of a business. Taking an example of the previous Pfizer case, where it split and sold off a business to merge with another company, Organon has agreed to notify and negotiate with the labor union before the final action. Also, MSD Korea, Organon Korea and MSD Korea Labor Union swore to mutually cooperate during the process of corporate split-off or employment relations and condition settlement. And they clarified the labor union members would not be discriminated. The latest agreement would affect the remedy requested for the unfair transfer in last December. Resisting against the transfer ordered without consent, the MSD Korea Labor Union filed a remedy for unfair transfer to the Seoul Regional Labor Relations Commission. Meanwhile, Organon Korea is to kick off from next month with Senior Director Kim So-eun as the first CEO.
- Company
- Evenity can be prescribed at general hospitals
- by Eo, Yun-Ho Jan 25, 2021 06:21am
- According to related industries, Amgen's bone formation promotion and bone resorption inhibitor Evenity (Romosozumab) has so far been prescribed in Big 5 general hospitals such as SMC, SNUH, Seoul St. hospital, AMC, and Shinchon Severance Hospital, and has passed the drug commitee (DC) of about 30 medical institutions such as Gangnam Severance Hospital, Pusan National University Hospital, Bundang Seoul National University Hospital, and Hanyang University Hospital. Amgen submitted an application for registration about one year after Evenity's domestic approval in May 2019, and was recognized for the adequacy of benefits from the HIRA's Pharmaceutical Benefit Advisory Committee in September. The approved indications are ▲treatment of postmenopausal female osteoporosis patients at high risk of fracture, and ▲higher bone density of male osteoporosis patients at high fracture risk. However, the benefit was limited to patients who were unable to use or were unable to use one or more of the bisphophonate drugs (although new fractures occurred despite sufficient administration for more than 1 year). The duration of administration is limited to a total of 12 times at intervals of one month from a lifetime, and when the bone density test is performed after the administration of the drug and the same or improvement compared to the baseline value is confirmed, the administration to a bone resorption inhibitor is permitted. However, as the registration process for new osteoporosis drugs in Korea was not easy, the registration of Evenity is encouraging. In the case of Forsteo (Teriparatide)', it took 10 years to register after approval. Professor Deok-yoon Kim of the Department of Endocrinology at Kyung Hee University Hospital said, "It is important to lower the risk of fracture with powerful drugs such as Evenity from the beginning of treatment for the ultra-high risk group for osteoporosis fracture. The application of Evenity is expected to enable customized treatment for the ultra-high risk group." The effectiveness of Evenity was confirmed through a phase 3 study FRAME and ARCH study, and a phase 3 clinical BRIDGE study in men with osteoporosis. Through FRAME, a placebo-controlled phase 3 clinical trial, Evenity showed the effect of lowering the risk of vertebral fracture in postmenopausal female patients with a high risk of fracture from -2.5 to -3.5 in anterior hip or femoral neck bone density T-score. In ARCH, an Alendronate-controlled phase 3 clinical trial, Evenity demonstrated superior preventive effects in both vertebral and clinical fractures compared to Alendronate in postmenopausal female patients with osteoporosis and fragile fractures. In the group that switched to Alendronate after 1 year of Evenity treatment, the risk of new vertebral fractures was reduced by 50% at 24 months compared to the continuous Alendronate group.
- Company
- KanghanLaw scouted Adviser Jaehong Kwon from BMS Korea
- by Eo, Yun-Ho Jan 25, 2021 06:21am
- Advisor Jaehong KwonKanghanLaw hired Jaehong Kwon (60 yrs old), an advisor from BMS, a multinational pharmaceutical company. According to the industry, former chief executive Jaehong Kwon, who retired from Korea BMS in August last year, officially joined KanghanLaw on January 1st. Adviser Kwon is an industry veteran with 34 years of experience who joined JW Pharma in 1986 and has worked at BMS Korea since 1998. KanghanLaw is planning to strengthen his expertise in the healthcare field with the recruitment of Advisor Kwon. He has been in charge of registering insurance benefits for new drugs such as 'Plavix','Baraclude', and 'Sprycel' as an expert in the pharmaceutical industry policy (GA, Government Affairs) and drug price (MA, Market Access) work. KanghanLaw is a law firm specialized in the field of health and welfare. This law firm has experienced attorneys, professional groups from health insurance companies such as The HIRA, BMS Korea, and global pharmaceutical companies, and Jooseong Kang, former president of the Health Right Network.
- Company
- ↑sales of chronic disease drugs & ↓sales of antibiotics
- by Chon, Seung-Hyun Jan 22, 2021 06:28am
- Despite COVID-19 epidemic, the chronic disease treatment market continued to grow. The market for antibiotics and expectorants declined significantly due to the decrease in cold patients due to strengthening hygiene management. According to UBIST, a drug research institute on the 19th, the prescription amount of statin drugs used to treat dyslipidemia last year was ₩1 trillion, an increase of 3.4% from the previous year. The prescription amount in 2019 was ₩976.5 billion won, an increase of 2.9% from the previous year, but the growth rate was higher last year. Statin sales increase every year. In 2017 and 2018, prescriptions increased 4.1% and 6.1% respectively from the previous year. Last year, it surpassed ₩1 trillion for the first time, continuing the growth trend, even though external activities of people were greatly reduced due to the aftermath of COVID-19. In the major chronic disease treatment prescription market, which forms a large market, there was little impact on COVID-19. The combination of calcium channel blocker (CCB) and angiotensin II receptor blocker (ARB), which are the most commonly used treatments for hypertension, recorded ₩811.3 billion in prescriptions last year, up 10.1% from the previous year. In 2019, it recorded an even greater growth rate than the prescription price growth rate of 6.9%. ARB+CCB combination drug prescription performance also increased 11.8% and 13.2% in 2017 and 2018 compared to the previous year, respectively. Last year, even in COVID-19 situation throughout the year, it continued high growth. The Lipid-regulating drugs, which have recently been increasing in demand, remained strong. Last year, the prescription size of the lipid-regulator combination drug was ₩633.5 billion, an increase of 21.0% from the previous year. The prescription market for lipid-regulating drugs increased by 10.2% and 15.1%, respectively, compared to the previous year in 2018 and 2019, but last year the growth trend was even steeper. In recent years, Rosuvastatin or Atorvastatin combined with Ezetimibe has continued to rise as preference for drugs has increased. The sales for the combination of DPP-4·Metformin, which is used as an ARB single drug or diabetes treatment, also rose. Last year, the market size of ARB single drug was ₩401.2 billion, an increase of 3.9% from the previous year, and DPP-4·Metformin combination drug increased 1.2%. In the industry, the use of medicines continues to increase due to the increase in the elderly population and the number of chronic diseases, so it is diagnosed that the entire industry will not contract due to short-term issues such as infectious diseases. Unlike the tourism and cultural industries, which fell into extreme crises after COVID-19 outbreak, the pharmaceutical industry is unlikely to lead to a sudden downturn because it is affected by the demands of patients rather than the external environment. The entire prescription market last year maintained a growth trend, while the chronic disease treatment market, which has a large prescription, was not affected by COVID-19. Last year, the total outpatient prescription amount was ₩14.85 trillion, up 0.2% from the previous year. Compared to the previous year, the growth trend has slowed somewhat, but it is evaluated that it has made good progress considering the big bad news of COVID-19. The slowdown in the growth of the entire prescription market can be found in the decline in sales of infectious diseases treatments such as antibiotics and expectorants. The prescription performance of oral Cephalosporins last year was ₩209.9 billion, down 20.6% from 2018. For oral Cephalosporins, the prescription amount in 2019 fell 1.5% from the previous year, but last year the decline has expanded significantly. Sales of oral Penicillin recorded ₩116.9 billion last year, down 34.9% from the previous year. In 2019, it fell 4.5% from the previous year, but last year, the total prescription size decreased by about a third. The size of prescriptions for expectorant drugs, which are widely used in pediatric patients, has also decreased significantly. Last year, the prescription for expectorant drugs was ₩124.8 billion, a 29.6% decrease from the previous year. The slowdown in the prescription market for antibiotics and expectorants is evaluated to be closely related to the decline in the number of patients. It is analyzed that after the spread of COVID-19, external activities contracted and personal hygiene management such as hand washing and wearing of masks was strengthened, leading to a decline in the incidence of infectious diseases such as colds.
- Company
- The sales of flu treatment fell 99.6% due to COVID-19
- by Chon, Seung-Hyun Jan 22, 2021 06:26am
- Last year, sales of influenza drugs fell more than 60% from the previous year. The prescription of Tamiflu, the most commonly used, has dropped sharply. In the fourth quarter of last year, the season of full-fledged flu, prescriptions for Tamiflu and generics decreased by more than 99%. As the number of flu patients sharply declined due to reinforced hygiene management following the spread of the new COVID-19, the market for treatments also shrank. According to the drug research institute UBIST on the 21st, the amount of outpatient prescriptions for flu treatments last year was ₩8.4 billion, a 61.8% decrease from the previous year. It has shrunk from ₩44.7 billion in 2019 to one-fifth in two years. This is the change in the prescription market due to the spread of COVID-19. After the COVID-19 epidemic, external activities contracted, and personal hygiene management such as hand washing and wearing of masks strengthened, greatly reducing the number of flu patients, and the market for treatments decreased. Sales of Tamiflu, the most used flu treatment drug, declined significantly. Last year, the outpatient prescription amount of Oseltamivir was ₩6.7 billion, down 60.2% from the previous year. It decreased by more than 80% in two years from ₩33.8 billion in 2018. Oseltamivir is the active ingredient of Tamiflu. Influenza drugs, including Tamiflu, are usually prescribed in the first and fourth quarters of the flu epidemic. In the first quarter of last year, the prescription amount of Oseltamivir was ₩6.7 billion, an increase of 20.4% from the previous year. Although the first confirmed cases of COVID-19 occurred on January 20 of last year, the flu treatment market was not significantly affected in the first quarter as the epidemic began in earnest after February. However, even though the flu season began in earnest in the fourth quarter of last year, Oseltamivir prescriptions were less than ₩100 million. It decreased by 99.6% from ₩5.9 billion in the fourth quarter of 2019 to ₩20 million in the fourth quarter of last year. As COVID-19 pandemic continues throughout the year, the flu treatment market has virtually disappeared. According to the KCDA, the number of suspected flu patients per 1,000 outpatients in December last year (weeks 49 to 52) was 2. 2.8 people at week 49, 2.8 people at week 50, 2.8 people at week 51, and 2.5 people at week 52, never exceeding 3 people. Compared to 2019, 19.5 people at 49 weeks, 28.5 people at 50 weeks, 37.8 people at 51 weeks, 49.8 people at 52 weeks , the flu patients rarely occurred. The prescription cost for all Oseltamivir products decreased significantly. Tamiflu's prescription amount last year was ₩2.8 billion, down 56.0% from the previous year. Tamiflu's prescription performance in the fourth quarter of last year was ₩23 million, down to 1% of ₩2.3 billion a year earlier. Sales of Hanmi Flu amounted to ₩1.6 billion last year, down 68.0% from 2019. Hanmi Flu recorded a prescription amount of ₩1.7 billion in the fourth quarter of 2019, but was only around ₩1 million in the fourth quarter of last year.
- Company
- Pharmaceutical industry rushes to recruit new GA managers
- by Eo, Yun-Ho Jan 22, 2021 06:26am
- The pharmaceutical industry is hectic seeking for government affairs specialists to recruit. An industry source reported, many of pharmaceutical companies and Korean Research-based Pharmaceutical Industry Association (KRPIA) are in search of new government affairs or market access managers, as their previous members are transitioning to other places. As the current healthcare policy director at KRPIA, Kang Tae-wook, was offered to teach at Sungshin Women’s University as a professor, the organization is looking for a successor. Before joining KRPIA in 2019, Director Kang was a healthcare policy researcher at the National Health Insurance Service (NHIS). Bayer Korea is in process of recruiting a Market Access-Government Affair Head, as the previous senior director of the department, Park Hanra moved to Bristol Myers Squibb (BMS). Organon, split from MSD, has decided to introduce Pyo Jihyun, a previous Policy and Stakeholder Relations Team Lead at Pfizer, as their new Head of Market Access, Government Affairs and Public Relations department. Pyo is expected to officially join Organon from coming February. Losing the key player in the company, Pfizer is also expected to search for a new lead in the team. Fine-tuning the new organization, Organon is looking for two more personnel to take over the government affairs and PR. Manager Paik Hee-jeong, previously worked at MSD, is decided to join the Organon market access department. Boehringer Ingelheim is newly recruiting a healthcare policy manager. Initially the company’s market access and government affairs were jointly managed by Senior Director Kim Mi-kyung, but the company has decided to hire another staff to solely manage the government affairs. Handok is also seeking a new market access manager as its previous Market Access Team Lead Park Sun has moved to UCB Korea. A government affairs manager at a multinational pharmaceutical company commented, “Because the job requires a specific skill set and experience, the companies inevitably looks for the new personnel within the industry. And that is why there is a chain of recruits and personnel assignment. Sometimes, however, companies look for someone from the National Assembly or news media for the government affairs.”
- Company
- Viatris·Organon's prescription performance declined
- by Kim, Jin-Gu Jan 22, 2021 06:26am
- Sales of major items owned by Viatris and Organon, which were spun off from Pfizer and MSD, are declining in the domestic outpatient prescription market. As of last year, Viatris' outpatient prescriptions fell 4% and Organon's 6% YoY. The decline in prescription results for most major items, such as Viatris' Lipitor·Lyrica and Organon's Singulair·Cozaar, has not been avoided. The prescription performance of the headquarters of Pfizer and MSD, which spun off its business divisions centering on patent-expired drugs, was relatively insignificant. ◆Viatris'L ipitor· Lyrica, 4% reduction in prescription performance According to UBIST, a drug market research organization on the 19th, Pfizer's outpatient prescription last year was ₩539.2 billion. Compared to ₩565.4 billion in 2019, it decreased by 11%. In 2018, Pfizer decided to spin off Pfizer Upjohn, focusing on drugs whose patents expired. Pfizer Upzone was officially launched in November last year under the name Viatris. However, the transfer and acquisition of Pfizer and its items has not been completed. Pfizer decided to hand over ▲Lipitor ▲Norvasc ▲ Lyrica ▲Celebrex ▲Viagra ▲Caduet ▲Neurontin ▲Xalatan ▲Cardura XL ▲Zoloft ▲Xanax ▲EfexorXR ▲Detrusitol ▲Zeldox ▲Xalacom ▲Zyvox to Viatris. The total amount of prescriptions for these items decreased by 4% from ₩453.1 billion in 2019 to ₩434.2 billion last year. Lipitor, the flagship product, was the most sold drug in the domestic outpatient prescription market for three consecutive years until last year, but it has been stagnant. The prescription amount last year was ₩185.5 billion, a 3% decrease from the previous year (₩191.4 billion). During the same period, Lyrica was 4% (₩67.3 billion → ₩64.5 billion), Celebrex 8% (₩44.3 billion → ₩40.4 billion), Caduet 15% (₩26.4 billion → ₩22.4 billion), Neurontin 14% (₩22.4 billion → ₩19.3 billion), Xalatan decreased by 1% (₩14.7 billion → ₩14.6 billion), respectively. Among the major items, only Norvasc increased by 1% (₩66.7 billion → ₩67.2 billion). The amount of outpatient prescriptions for the remaining items at Pfizer decreased by 7% from ₩112.3 billion to ₩10.5 billion. Compared to simple comparisons, Pfizer's remaining items declined more, but given the fact that the recent growth of anticancer drugs such as Ibrance and Xalkori, which have a large proportion of inpatient prescriptions, and vaccines such as Prevenar13, the actual decrease in prescription performance is not significant. ◆Excluding Organon's Atojet, Singulair and Proscar sharply decreased by around 10% MSD also decided to spin off some of the patent expired drugs, women's health products, and biosimilars. The name of the spin-off company is Organon. The items passed from MSD to Organon are ▲Atozet ▲Singulair ▲Vytorin ▲Proscar ▲Cozaar ▲Fosamax ▲Nasonex. Among them, prescription performance for other items excluding Atozet decreased significantly: Cozaar series 3% (₩52.4 billion → ₩50.6 billion), Singulair 29% (₩38.1 billion → ₩26.8 billion), and Vytorin 18% (₩24.8 billion → ₩20.3 billion). , Proscar 10% (₩19.1 billion → ₩17.2 billion), Fosamax series 9% (₩16.7 billion → ₩15.2 billion), and Nasonex 13% (₩8.2 billion → ₩7.2 billion), respectively. Atozet rose 14% from ₩65.8 billion to ₩74.7 billion. However, it is unclear how long Atozet's uptrend will continue. Generics for Atozet are expected to be listed as early as next month. Currently, it is known that about 20 companies, mainly Chong Kun Dang, are developing generics. MSD has decided to leave the Januvia series the only drug that has expired. The Januvia series' prescription performance last year was ₩176.2 billion, a 5% increase from the previous year (₩168.2 billion). The total outpatient prescriptions for items remaining in MSD, including Januvia, increased by 2% from ₩207 billion in 2019 to ₩29.9 billion last year. MSD plans to close the spin-off process with Organon in February. Currently, some of the 700 employees of MSD Korea have been relocated.
- Product
- Efficacy vs. More inoculation? Vaccination plan in dilemma
- by Choi-sun Jan 22, 2021 06:26am
- The public is questioning the actual efficacy of the alternative regimen of the COVID-19 vaccine that reduces dose or delays the booster dose due to the vaccine shortage, Relevant experts give conflicted opinions. Some argue the government should maximize the efficacy with the limited resource, whereas some claim medical evidence is integral before making a hasty decision. ▲Three conflicts: delaying second dose, switching vaccine type and reducing dose volume The main considerations on the vaccine inoculation plan are spacing out the vaccine interval designed at the clinical phase, switching between vaccine types, and lessening the vaccine dose instead of delaying the interval. All conflicts are caused by the shortage in the COVID-19 vaccine. The health authority means to distribute the limited vaccines as much as feasible. Professor Kim Woo-joo at Korea University Hospital Department of Infectious Diseases said, “Delaying the second dose timing, although it has not been scientifically proven, would be cost-effective to immediately block off the COVID-19 transmission and to minimize the damage. But it does not have to be considered as South Korea’s situation is as not urgent as the situation in the U.K.” ▲Experts OK delaying second dose Vaccine and infectious disease experts show open stance on the longer vaccine interval. As the second dose serves as a booster for the first dose, they claim taking the two doses is more important than the timing. Professor Choi Yong-jun of Hallym University College of Medicine explained, “When it comes down to vaccine inoculation, a short interval can be problematic, but delaying it does not raise a concern. This is one of basic principles of vaccine inoculation.” The booster dose activates the immunocytes and antigen memory inducing the antibody reaction after the first dose. The second dose is only needed as a single shot of vaccine cannot guarantee 100-percent immunogenicity. In other words, the longer interval does not drastically affect the efficacy of the vaccine. ▲On switching the vaccine types, ”Absolutely not” Meanwhile, the experts are leaning towards an absolute negative stance on mixing the vaccine types. The U.K. authority considered inoculating Pfizer vaccine for the first dose and AstraZeneca vaccine for the second, but they had to withdraw the plan after the public criticism that there is not enough clinical evidence to ensure safety in the switch. Director Kang Jin-han at the Catholic University of Korea Vaccine and Bio Research Center firmed noted “The vaccine type switching is definitely not advisable. There is no evidence and it is unethical.” With a concerned voice, he added, “The clinical trial protocol on confirming the efficacy of a COVID-19 vaccine was conducted twice with the same vaccine type. Nobody knows what would happen when using two types of vaccines.” ▲Unsure of the low-dose inoculation Then, how about inoculating a lower dose vaccine, instead of a full dose? The experts carefully say the efficacy should be verified first. Theoretically, the full-dose inoculation would be idealistic to confirm the efficacy, but strangely there was a case a vaccine performed better with lower dose. During the Phase II/III trial on AstraZeneca’s vaccine candidate AZD1222, about 10,000 participants aged over 18 were inoculated twice with a month-long interval, and their prevention effect was checked after two weeks. The result found 2,741 people who received one dose achieved 90 percent of the effect, whereas 8,895 people with the two full doses only reached 62 percent. The vaccine efficacy improved by 28 percent-point with the one dosing regimen. Moderna disclosed research findings that half a dose of vaccine demonstrating similar effect with a full dose. Generally, lesser dose should show equivalent or inferior efficacy than the full dose, but AstraZeneca’s vaccine performed better with reduced dosing. Korean Society of Infectious Diseases (KSID) official pointed out, “The appropriate evidence of a lower dosing performing better than higher dosing cannot be found. We need a large scale clinical trial for more credible source of evidence.” ▲The health authority’s decision based on vaccine supply " The daily confirmed case count of COVID-19 in South Korea has dropped under 500. Taking account of the situation, the radical inoculation plan to switch the vaccine type or delaying the booster dose sound unrealistic at the moment. The Ministry of Food and Drug Safety (MFDS) official stated, “Except for an alarming crisis in the pandemic control, vaccination should be based on the label approved by the clinical evidence. The research data on lower dosing regimen and longer vaccine interval could be used for the inoculation plan, if need be.” Korea Disease Control and Prevention Agency (KDCA) plans to review all possibilities, as there is some time left until the vaccine supply arrives and the inoculation starts. The agency official also added, “The detailed would be unveiled later, but the agency is carefully setting up the vaccination plan by referring to experts’ opinions.”
- Company
- Takeda to retry expanding all-comer coverage on Zejula
- by Eo, Yun-Ho Jan 21, 2021 06:15am
- An all-comer targeting anticancer treatment Zejula is shooting yet again for the healthcare reimbursement expansion this year. The pharmaceutical industry insider reported the drug could not overcome the hurdle of the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee in last June, but the poly ADP-ribose polymerase (PPARP) inhibitor Zejula’s (niraparib), applied again in last August to expand the reimbursed indication. On Jan. 27, the Cancer Deliberation Committee would assess expanding the healthcare reimbursement on the drug’s indication as a monotherapy for the patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first-line platinum-based chemotherapy, regardless of BRCA mutation. In last June, the Cancer Deliberation Committee reviewed using the drug as a single-agent maintenance therapy in patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as a monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy. Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed. But the government is still cautious of expanding the reimbursement on all-comer indication. The indication approval was based on the PRIMA study that evaluated Zejula’s efficacy as a first-line maintenance therapy on 733 adult patients diagnosed with ovarian cancer. The primary endpoint was a progression-free survival (PFS) in homologous repair deficiency (HRD) and overall population groups, which was evaluated by the Blinded Independent Central Review (BICR) in the order. The clinical study found the HRD patient group demonstrated a median PFS of 21.9 months, almost doubling that of the placebo group, and reduced the risk of disease progression and death by 57 percent. The control group’s median PFS marked 10.4 months. The overall population’s median PFS was 13.8 months with Zejula and 8.2 months with the placebo. The risk of disease progression and death was lessened by 38 percent. Professor Kim Jae-weon at Seoul National University Hospital Depart of Obstetrics and Gynecology noted, “The maintenance therapies each in first-line and second-line show a significant difference. Obviously, the survival rate goes up when the treatment is used at an earlier stage. Personally speaking, the healthcare coverage on the first-line maintenance therapy should be expanded for all possible patients.” Originally, Zejula’s reimbursed price was set at 76,400 won per capsule. Compared to the alternative option, Lynparza (olaparib) by AstraZeneca, Takeda’s option was evaluated as more cost-effective. But because Lynparza was listed with a pharmacoeconomic-analysis exemption through the risk sharing agreement (RSA), Zejula was also applied with the expenditure cap type RSA.
- Policy
- GemVax dementia drug candidate is reviewed for PSP
- by Lee, Tak-Sun Jan 21, 2021 06:14am
- It is considering clinical trials to verify the new drug candidate GV1001, which GemVax is developing as a treatment for Alzheimer's disease, for the rare disease progressive supranuclear pals. However, the Central Pharmaceutical Affairs Review Committee, an expert advisory body from the MFDS, has postponed the judgment that additional data are needed. The minutes of the Central Pharmaceutical Affairs Review Committee released by the MFDS on the 20th are as follows. The meeting held on the 11th of last month was to consult with GV1001 on the feasibility of conducting a clinical trial for patients with progressive supranuclear pals. GV1001 is a treatment for Alzheimer's disease that GemVax is developing. In Korea, phase II clinical trial have been conducted for moderate patients and are currently pursuing phase III trial. In addition, it has been approved for phase II clinical trial in the US, and is aiming to begin in the first half of this year. GV1001 is the same active ingredient as Riavax, which is licensed as a treatment for pancreatic cancer. It is being developed as a treatment for dementia by changing its use. However, Riavax was canceled in August of last year because it did not meet CMA criteria. According to the minutes of the meeting, the MFDS currently has no cure for progressive supranuclear pals. Given that the applied clinical trial is an Investigator-Sponsored Trial, not a Sponsor-Initiated Trial, it was judged that it was necessary to consider approving a clinical trial protocol if it could help progressive supranuclear pals. Advisors to the Central Pharmaceutical Affairs Review Committee pointed out that there are no animal studies and data on the results of phase II clinical trial for Alzheimer's disease are insufficient. It could be considered by submitting additional data. One member said, "Progressive supranuclear pals themselves are rare, and the speed of progression is so fast that it will be difficult to predict with an animal model. The validity of the dose is a safety issue. If there is data, we can consider approving the clinical trial protocol.” The chairman said, "It is necessary to submit data that can link Alzheimer's disease and progressive supranuclear pals to determine whether to replace the advanced progressive supranuclear pals animal model effect data with the Alzheimer's disease animal model effect data." "Let's review the results of the phase II clinical trial for sick patients." The committee members put emphasis on the fact that the results of phase II clinical trial for Alzheimer's disease are summary data, so it is necessary to review the full report. The MFDS concluded, "We will submit additional data according to the results of the meeting," and concluded that "We will determine whether to replace the effective data after receiving the data to prove the correlation between progressive supranuclear pals and Alzheimer's disease." It added, "We will ask for additional advice if necessary after we have received a report on the results of a phase II clinical trial for patients with Alzheimer's disease and reviewed it by the MFDS." Progressive supranuclear pals are rare diseases that cause degeneration of nerve fibers in the cerebral cortex and subcortical tissues, and cause Parkinson's symptoms such as gait disorders and impaired intelligence. Onset in their 50s to 60s and worsening symptoms lead to death. There is no special treatment and an urgent need for a cure.
